ELEMENT I.1.B.

ELEMENT I.1.B.: The organization delegates responsibility for the Human Research Protection Program to an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program.

An organization should have an identified, knowledgeable leader of the HRPP who is responsible for the program and has the authority to implement the program. Although this individual may rely on others for the interpretation of laws, regulations, codes, and guidance and the day-to-day operations of the HRPP, this individual should have a basic understanding of the relevant laws, codes, regulations and guidance that govern research involving human participants, the responsibilities of an organizational official, and the responsibilities of the IRB or EC and researchers and research staff in protecting research participants. This individual should be directly involved in the allocation of resources to the HRPP. In some circumstances, more than one individual serves in this capacity.

This Element is applicable to all organizations, regardless of whether the organization has a federal assurance of compliance. If an organization has a federal assurance of compliance, the identified leader of the HRPP might or might not be the official who signs the assurance

Regulatory and guidance references

DHHS: 45 CFR 46.103(c)
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
VA: VHA Directive 1200.05(3) sections 5 and 7; VHA Directive 1200.01(1) section (5)

Required written materials

Essential requirements:
1. Policies and procedures describe the responsibilities of the organizational official.
2. If more than one person is designated as an organizational official, the unique responsibilities of each individual that relate to the HRPP are stated.
When following DOE requirements:
1. No human participant research conducted with DOE funding, at DOE institutions, regardless of funding source), or by DOE contractor personnel (regardless of funding source or location conducted), and whether done domestically or in an international environment, including classified and proprietary research, may be initiated without both a Federalwide Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) and approval by the cognizant IRB in accordance with 10 CFR Part 745.103.
2. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) must be notified in writing prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt HSR as outlined in 10 CFR Part 745.104, that involves:
  1. An institution without an established IRB.
  2. A foreign country.
  3. A potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups).
  4. Research subjects in a protected class (prisoners, children, individuals with impaired decision making, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope.
  5. The generation or use of classified information.
When following VA requirements:
1. For VA facilities:
  1. Policies and procedures describe the responsibilities of the VA medical facility director and how they are implemented.
    1. Serving as the organizational official for the medical facility. The organizational official is the individual legally authorized as signatory official to commit an institution to an FWA.
    2. Overseeing the facility’s research program. The organizational official is responsible for the creation and implementation of an HRPP for research involving human participants.
    3. Ensuring that the institution’s HRPP functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human participants.
    4. Overseeing the R&D Committee, IRB, and other applicable subcommittees of the R&D Committee, facility research office, and all VA researchers and VA research staff who conduct human participants research at that facility.
    5. Delegating authority in writing for respective roles and responsibilities for the HRPP. This delegation of authority must provide the organizational structure and ensure leadership for oversight activities for all human participants research conducted at or by the facility.
    6. Ensuring provision of adequate resources to support the operations of the HRPP.
    7. Ensuring independence of the IRB.
    8. Appointing VA voting members to an IRB in writing. Appointment procedures for ex officio, non-voting members are made according to local SOPs and any other applicable VA requirements. Voting members of VA IRBs and VA representatives to external IRB(s) of Record are appointed for a period of up to three years. They may be re-appointed to new terms of up to three years without a break in service at the end of each term.
    9. Appointing the chair and, when applicable, co-chair(s) or vice chair(s) for a term of up to three years when the VA facility operates its own IRB.
    10. Serving as the official representative of the institution to external agencies and oversight bodies, and providing all written communication with external departments, agencies, and oversight bodies.
    11. Ensuring that a procedure is in place to review and approve recruiting media, including documents, flyers, and advertisements for research that is not VA research prior to being posted or distributed in any form within or on the premises of a VA facility. Posting or distributing may include announcing, distributing, publishing, or advertising the study either electronically, by hard copy, or other means to anyone, including Veterans, clinicians, or other staff.
    12. Ensuring that a documented procedure is in place for determining when a research activity approved by the IRB, prior to January 21, 2019, can transition to the 2018 Requirements, if applicable. The documented procedure must list what individuals or groups are designated to make the determinations. Researchers may not make a determination that their studies can be transitioned to the 2018 Requirements.
    13. Ensuring appropriate documentation of required actions and responsibilities pertaining to review, approval, conduct and oversight of research conducted at that facility.
    14. Ensuring all research subject to VHA Directive 1200.05 is reviewed and approved by an IRB and will be subject to oversight by the IRB. (Research that meets the exempt categories is not subject to IRB review unless it is determined to meet one of the exempt categories requiring limited IRB review. All exempt research must be reviewed and approved by the R&D Committee.)
    15. Ensuring that any IRB operated by the VA facility is established in accordance with the requirements of VHA Directive 1200.05 and registered through VA Office of Research Oversight (ORO) with OHRP.
      1. The facility’s IRB(s) of Record may include the facility’s own IRB(s), VHA Central Office IRB (VA Central IRB), an IRB of another VA facility, the IRB(s) of a medical or dental school, or the IRB of another Federal agency. A facility may also use an IRB for multi-site protocols that has been specifically designated by VA Office of Research & Development (ORD) as an IRB that may serve as a multi-site IRB for VA facilities. (See Standard I-9)
      2. VA will permit use of a commercial IRB as an IRB of Record for VA facilities if it has been specifically designated by ORD as a commercial IRB that may serve as an IRB for cooperative research. (See Standard I-9)
      3. A VA facility’s own IRB, also known as an internal IRB, and the VA Central IRB, cannot serve as an IRB of Record for any non-VA entity except a Department of Defense (DoD) facility, Department of Energy laboratory, or a VA-affiliated nonprofit research and education corporations (NPC).
  2. When the facility engages the services of another entity’s IRB as its IRB of Record, the organizational official is responsible for:
    1. Establishing and signing a Memorandum of Understanding (MOU) or Authorizing Agreement with other VA facilities or external organization(s) providing IRB services.
    2. Ensuring that external IRBs of Record used by the VA facility hold current IRB registrations with FDA and OHRP and provide updates to membership.
    3. Policies and procedures describe the responsibilities of the Research and Development Committee (R&D Committee) and how they are implemented:
    4. Assisting the medical facility Director in fulfilling responsibilities for the facility’s research program by making recommendations regarding personnel, space and other resource needs of the research program.
    5. Reviewing research proposals:
      1. Approving the research, requiring modifications to obtain approval, or disapproving the research. The R&D Committee can disapprove research approved by the IRB or another one of its subcommittees, but is not permitted to approve research that has been disapproved by an IRB or other appropriate subcommittee.
      2. Suspending or terminating a research protocol.
      3. Suspending a researcher’s or a research staff member’s privilege to conduct research pending appropriate investigation and decision by the medical facility Director.
      4. Require the implementation of additional safeguards related to the safety of human participants.
    6. Ensuring the effective operation of the facility research program through oversight of all R&D Committee subcommittees and the facility’s research portfolio.
    7. Ensuring that all research in which the facility is engaged is consistent with the VA mission and complies with all applicable statutory and regulatory requirements.
    8. Establishing appropriate subcommittees to review and oversee human participants research.
    9. Ensuring Information System Security Officer (ISSO) review of studies that involve the collection, processing, storage, and transmission of research data and Privacy Officer (PO) review of studies using human data are complete before a study is given final approval.
    10. Determining whether the facility should participate in a study and ensuring that the appropriate IRB agreements are in place.
    11. Establishing procedures to ensure that all research in which the facility is to be engaged has been reviewed and approved for high scientific quality, the protection of human participants and research staff, the welfare of animal subjects, the safety of all involved in research, the security of research laboratories, and the security of VA data and VA sensitive information.
    12. Ensuring that classified research is not conducted as VA research.
    13. Reviewing the operations of all research-related committees and subcommittees as an ongoing function.
    14. Fulfilling such other functions as may be specified by the medical facility director, ORD, and VHA leadership.
  3. Requesting VA Chief Research & Development Officer (CRADO) approval when the VA facility wants to establish a new HRPP, change its IRB(s) of Record, or wants its internal IRB to serve as an IRB of Record for a non-VA entity.
  4. Submitting waiver requests electronically to the CRADO for approval of research involving prisoners conducted by VA researchers while on official VA duty.
  5. Approving VA participation in proposed research that includes pregnant women, neonates, or children as described in VHA Directive 1200.05.

Common types of materials that may be used to meet the element

Letter or memorandum from senior management stating the delegation
Job description of the organizational official

Outcomes

The organizational official has overall responsibility for the HRPP.
The organizational official is identifiable by those within the organization.
The organizational official has sufficient standing, authority, knowledge, and independence to ensure implementation and maintenance of the program.

Proceed To: ELEMENT I.1.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.1.B.